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Nexus Pharmaceuticals v. Nevakar & Endo — Ephedrine IV Patent Dispute | PatSnap
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Case ID1:22-cv-05683
FiledSep 2022
ClosedMar 2025
Patent Litigation

Nexus Pharmaceuticals v. Nevakar & Endo: Ephedrine IV Patent Battle Closes After 907 Days

Nexus Pharmaceuticals asserted three patents covering its EMERPHED® ephedrine sulfate 5 mg/mL IV solution against Nevakar, Endo International, and Par Pharmaceutical in New Jersey federal court. The case ran for 907 days before termination, with the public record reflecting procedural sealing activity as the final docketed ruling.

Resolution time
907days
907 days — above the median for multi-defendant pharmaceutical patent cases in D.N.J.
Patents asserted
3
US11426369B2, US11571398B1, and US11464752B2 — three ephedrine sulfate IV formulation patents asserted
Outcome
Case Terminated
Case terminated; basis of termination does not specify settlement, dismissal with or without prejudice, or merits adjudication.
Cost ruling
Not recorded
No cost or fee ruling is reflected in the publicly available case record.
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Three-Patent IV Formulation Fight Ends Without Public Merits Ruling

On 23 September 2022, Nexus Pharmaceuticals, Inc. filed suit in the U.S. District Court for the District of New Jersey against Nevakar, Inc., Nevakar Injectables, Inc., Endo Ventures Ltd., Endo International PLC, Par Sterile Products LLC, and Par Pharmaceutical, Inc. Nexus alleged infringement of three patents — US11426369B2, US11571398B1, and US11464752B2 — each directed at ephedrine sulfate IV formulations. The accused products included Nevakar’s prefilled syringe product and, by extension, the downstream commercialisation chain involving the Endo and Par entities.

The case was formally terminated on 18 March 2025 after 907 days. The publicly available docket does not specify whether termination followed a settlement agreement, a voluntary dismissal, a consent judgment, or another mechanism. The last substantive ruling on record is a January 2025 order granting an unopposed motion to seal commercially sensitive regulatory and business strategy information — suggesting active litigation or negotiation was continuing close to the termination date.

A 907-day duration is consistent with cases that proceed through claim construction and discovery before resolving without a full trial, though the public record does not confirm this trajectory here. The sealing of business-sensitive correspondence in the final months suggests the parties may have been engaged in resolution discussions involving proprietary commercial terms. What drove the ultimate termination — and whether any licensing or commercial arrangement was reached — is not determinable from publicly available filings.

Case at a glance
Case no.1:22-cv-05683
DefendantNevakar, Inc.
CourtNew Jersey
JudgeN/A
FiledSeptember 23, 2022
ClosedMarch 18, 2025
Duration907 days
OutcomeCase Terminated
Verdict causeInfringement Action
BasisCase Terminated
Prior Art Intelligence
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Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Case Terminated in 907 days

907 days — above the median for multi-defendant pharmaceutical patent cases in D.N.J.

Case timeline: Complaint filed SEP 23 2022, DEC–JAN — 907 days total Horizontal timeline showing the three key events in Nexus Pharmaceuticals, Inc. v Nevakar, Inc. from filing to resolution. Source: PACER, New Jersey District Court. SEP 23 2022 Complaint filed Pre-trial proceedings MAR 18 2025 Case Terminated 907 DAYS TOTAL
Dismissal terms

Case terminated: what the public record does and does not reveal

Legal mechanism

Termination without a stated basis — what this means

A ‘Case Terminated’ entry without further specification means the docket was formally closed but the underlying mechanism — settlement, voluntary dismissal, consent order, or otherwise — is not publicly stated. It does not constitute a merits ruling. Either party could potentially have reserved rights depending on the actual resolution instrument, which may remain under seal.

No merits adjudication on record
Plaintiff outcome

Nexus’s patent rights: unresolved in the public record

Because no invalidity or non-infringement finding was entered publicly, Nexus’s three ephedrine sulfate patents — US11426369B2, US11571398B1, and US11464752B2 — remain nominally intact and enforceable. The termination does not signal a litigation loss for Nexus, but equally does not confirm any damages award or injunctive relief. The strength of these patents against future entrants is unchanged by the case outcome alone.

Patents remain enforceable
Defendant outcome

Nevakar, Endo, and Par face ongoing IP uncertainty

The Endo and Par entities, along with Nevakar, avoided a public adverse judgment. However, the absence of a declared invalidity ruling means they cannot rely on this litigation as precedent clearing the asserted patents. Any continued or relaunched commercialisation of ephedrine sulfate prefilled syringe products would require independent FTO analysis against the Nexus patent family. The sealing of late-stage commercial strategy materials suggests terms may have been negotiated privately.

No public patent clearance obtained
Commercial implications

IV formulation patent risk remains live for the sector

The case signals that Nexus is willing to assert its ephedrine sulfate formulation patents aggressively against both product developers and their commercialisation partners. With no public invalidity ruling, the Nexus patent family represents a standing litigation risk for any company developing or distributing competing IV ephedrine sulfate products, particularly in prefilled syringe formats targeted at hospital anaesthesia and critical care markets.

Formulation patents still in force
Legal analysis based on PACER docket records for case 1:22-cv-05683 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffNexus Pharmaceuticals, Inc.CompanyPharmaceutical company — holder of US11426369B2, US11571398B1, and US11464752B2 covering EMERPHED® ephedrine sulfate IV solutionSearch in Eureka ↗
DefendantNevakar, Inc.CompanyNevakar, Endo International, Par Pharmaceutical, and related entities — developers and distributors of competing ephedrine sulfate prefilled syringe productsSearch in Eureka ↗
Co-DefendantEndo Ventures, Ltd.CompanySearch in Eureka ↗
Co-DefendantNevakar Injectables, Inc.CompanySearch in Eureka ↗
Co-DefendantPar Sterile Products, LLCCompanySearch in Eureka ↗
Co-DefendantEndo International, PLCCompanySearch in Eureka ↗
Co-DefendantPar Pharmaceutical, Inc.CompanySearch in Eureka ↗
Plaintiff counselJustin Taylor QuinnAttorneyCounsel for Nexus Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmRobinson Miller LLCLaw FirmRepresenting Nexus Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselDarren M. GeliebterAttorneyCounsel for Nevakar, Inc.Search in Eureka ↗
Defendant law firmLombard & Geliebter LLPLaw FirmRepresenting Nevakar, Inc.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“This matter is before the Court on the unopposed Motion to Seal [ECF No. 291] filed by Defendants, Endo USA, Inc. and Endo Operations Limited (collectively, “Defendants”). Defendants seek to redact and seal portions of the Letter from Maureen T. Coghlan to the Hon. Chief Judge Renee Marie Bumb [ECF No. 286]. Defendants’ motion is supported by the Declaration of Aziz Burgy, Esquire [ECF No. 291-1] and an Index [ECF No. 291-2]. The Court exercises its discretion to decide Defendants’ motion without oral argument. See FED. R. CIV. P. 78; L. CIV. R. 78.1. For the reasons to be discussed, Defendants’ motion is GRANTED. It is well established that there exists “a common law public right of access to judicial proceedings and records.” In re Cendant Corp., 260 F.3d 183, 192 (3d Cir. 2001) (citing Littlejohn v. BIC Corporation, 851 F.2d 673, 677–78 (3d Cir. 1988)). This right of access is not absolute, however, and must be balanced against countervailing interests in secrecy. See Leucadia, Inc. v. Applied Extrusion Techs., Inc., 998 F.2d 157, 165 (3d Cir. 1993) (citation omitted); see also In re Cendant Corp., 260 F.3d at 194 (noting that “[t]he presumption of public access may be rebutted”). To overcome the presumption, a party must demonstrate that “good cause” exists for protection of the material at issue. Securimetrics, Inc. v. Iridian Techs., Inc., No. 03-4394, 2006 WL 827889, at *2 (D.N.J. Mar. 30, 2006). “Good cause exists when a party makes a particularized showing that disclosure will cause a ‘clearly defined and serious injury to the party seeking closure.’” Id. (quoting Pansy v. Borough of Stroudsburg, 23 F.3d 772, 786 (3d Cir. 1994)). In this District, motions to seal are governed by Local Civil Rule 5.3, which requires the moving party to describe with particularity: (a) the nature of the materials or proceedings at issue; (b) the legitimate private or public interest which warrants the relief sought; (c) the clearly defined and serious injury that would result if the relief sought is not granted; and (d) why a less restrictive alternative to the relief sought is not available. See L. CIV. R. 5.3(c)(3). “Generally, a court will protect materials containing ‘trade secret[s] or other confidential research, development, or commercial information’ to prevent harm to a litigant’s competitive standing in the marketplace.” Faulman v. Sec. Mut. Fin. Life Ins., No. 04-5083, 2006 WL 1541059, at *1 (D.N.J. June 2, 2006) (alteration in original) (citations omitted); see In re Gabapentin Patent Litig., 312 F. Supp. 653, 644 (D.N.J. 2004) (“A well-settled exception to the right of access is the ‘protection of a party’s interest in confidential commercial information, such as a trade secret, where there is a sufficient threat of irreparable harm.”); see also FED. R. CIV. P. 26(c)(1)(G). “Broad allegations of harm, unsubstantiated by specific examples or articulated reasoning,” however, will not establish good cause. Pansy, 23 F.3d at 786 (citation omitted). Furthermore, “a party’s classification of material as protected or confidential does not automatically satisfy the criteria for sealing pursuant to Local Civil Rule 5.3.” In re: Benicar (Olmesarten) Prods. Liab. Litig., No. 15-2606, 2016 WL 266353, at *3 (D.N.J. Jan. 21, 2016). The Court has reviewed the subject materials and finds that Defendants have sufficiently described the nature of the materials it seeks to redact and seal, and has asserted legitimate privacy interests which warrant sealing the materials. Defendants seek to redact and seal limited portions of the Letter from Maureen T. Coghlan to Hon. Chief Judge Renee Marie Bumb. See ECF No. 286. Defendants allege the subject materials contain highly sensitive business information, including proprietary, confidential, and commercially sensitive operations and regulatory strategies. See Burgy Decl. ¶ 4. If the subject materials are not sealed, Defendants contend public disclosure of the information would cause it to suffer competitive injury and give competitors an unfair advantage in the marketplace. See id. ¶ 5. The Court agrees the failure to seal the subject materials will result in serious injury to Defendants’ interests. The Court finds, as Defendants contend, if the subject materials were to become public, Defendants could be harmed by way of competitive disadvantage in the marketplace and injury to its business interests. Likewise, given the nature of the materials sought to be sealed and the narrow tailoring of Defendants’ request, the Court agrees that the only way to protect Defendants’ legitimate privacy interests is to redact and seal portions of the subject materials. Accordingly, for all the foregoing reasons, IT IS HEREBY ORDERED this 22nd day of January, 2025, that Defendants’ Motion to Seal [ECF No. 291] is GRANTED; and it is further ORDERED that the Clerk is directed to maintain under seal ECF No. 286, and it is further ORDERED that, to the extent not already done, Defendants shall file a redacted copy of ECF No. 286 in accordance with this Order by February 5, 2025.”
Source: PACER Docket, Case 1:22-cv-05683, New Jersey District Court

The most recent substantive ruling on public record is a procedural sealing order, not a merits determination. The court applied the D.N.J. Local Civil Rule 5.3 framework, finding that Defendants demonstrated good cause by showing disclosure of proprietary regulatory and commercial strategy materials would cause competitive injury. This ruling is significant context: it confirms that commercially sensitive negotiations or strategies were still live in January 2025, just weeks before the March 2025 case termination. It does not resolve infringement, validity, or damages.

PACER case 1:22-cv-05683 · Public docket record Explore in Eureka ↗
Patent at issue

US11426369B2, US11571398B1 & US11464752B2 — Ephedrine Sulfate IV Formulations

Publication No.US11426369B2
Application No.US17/556904
Patent details
ProductEphedrine sulfate IV solution formulation — EMERPHED® 5 mg/mL
Cited in actionSeptember 23, 2022

Publication No.US11571398B1
Application No.US17/943185
Patent details
ProductEphedrine sulfate injectable formulation compositions and methods
Cited in actionSeptember 23, 2022

Publication No.US11464752B2
Application No.US17/381770
Patent details
ProductEphedrine sulfate prefilled syringe IV delivery formulations
Cited in actionSeptember 23, 2022

The three asserted patents — US11426369B2, US11571398B1, and US11464752B2 — cover ephedrine sulfate intravenous formulations, with application numbers indicating relatively recent grant dates in the early 2020s. The patents protect EMERPHED®, Nexus’s commercially approved 50 mg/10 mL (5 mg/mL) IV ephedrine sulfate solution. Ephedrine sulfate is a vasopressor agent used perioperatively to treat intraoperative hypotension, particularly in the context of spinal anaesthesia during caesarean delivery — a high-volume, high-acuity hospital segment.

These patents sit within a competitive segment where hospital formulary decisions favour ready-to-use prefilled formats over traditional vial-based preparation. Nevakar’s accused product — a 25 mg/5 mL single-dose prefilled syringe — directly targets the same clinical indication and hospital procurement channel. The three-patent assertion strategy suggests Nexus has layered its IP protection across formulation composition, method of use, and delivery format, creating multiple validity and infringement vectors that any competitor must navigate independently.

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Freedom to operate

Should you run an FTO against US11426369B2, US11571398B1, and US11464752B2?

Any company developing, manufacturing, or distributing prefilled syringe or ready-to-use IV ephedrine sulfate products for the hospital anaesthesia market should treat this patent family as a live risk. The case termination without a public invalidity ruling means none of these patents has been adjudicatively cleared. EMERPHED’s market position in perioperative vasopressor therapy gives Nexus strong commercial incentive to continue enforcement against new entrants.

PatSnap Eureka’s FTO Search Agent allows R&D and regulatory teams to map their ephedrine sulfate formulation, concentration, and delivery format against each of the three Nexus patents in parallel. Eureka surfaces prior art, prosecution history, and claim scope analysis to help you identify design-around pathways or assess validity arguments before committing to clinical or commercial development in this product category.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US11426369B2 to assess your product’s exposure

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Strategic implications

What this case signals for the injectable pharmaceutical IP landscape

A 907-day multi-defendant dispute over IV ephedrine formulations highlights the complexity of hospital-segment pharmaceutical patent enforcement.

Multiple downstream defendants signals a full-chain enforcement strategy

Nexus named not just the product developer Nevakar but also Endo and Par entities spanning manufacturing and distribution. This pattern — asserting patents against the entire commercialisation chain — is increasingly common in specialty pharmaceutical litigation and raises the litigation cost calculus for all parties involved.

Late-stage sealing of regulatory strategy documents is a resolution signal

The January 2025 order sealing proprietary regulatory and operational strategy materials, filed just weeks before case termination, is consistent with active settlement negotiation. Parties rarely seek to protect commercially sensitive strategy documents unless those terms are material to an imminent resolution.

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Frequently asked questions

Nexus v Nevakar — key questions answered

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Track IV formulation patent risk before your next product decision

Use PatSnap Eureka to monitor the Nexus ephedrine sulfate patent family for continuations, IPR filings, or new enforcement actions. Run an FTO before committing to clinical or commercial development in the hospital IV vasopressor segment.

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